Soft dual layer rectal speculum

ABSTRACT

A soft dual-layer rectal speculum includes a main tube member having a distal end for insertion into a patient&#39;s rectum and a proximal end for connection to a waste removal hose where at least a portion of the main tube member includes an inner hard layer and an outer soft layer, and an inlet tube member for directing fluids into the main tube member. The inlet tube member may include a swivel mechanism and the portion of the main tube member having an inner hard layer and an outer soft layer may include a measurement gauge that is visible through the outer soft layer but can&#39;t be felt through the outer soft layer. A rectal speculum assembly includes the soft dual-layer rectal speculum described above and an obturator which includes an elongated member having a tapered distal end capable of extending through the distal end of the main tube member. The tapered distal end of the obturator may be made of a soft, pliable material or an inner hard layer (or member) and an outer soft layer.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims benefit of priority toU.S. Nonprovisional patent application Ser. No. 13/176,260 filed Jul. 5,2011, currently pending, which application claims the benefit of, andpriority to provisional patent application having Ser. No. 61/361,381,filed Jul. 3, 2010, which applications are hereby incorporated byreference in their entireties.

BACKGROUND OF THE INVENTION

The prior art includes numerous rectal speculums for use with colonhydrotherapy. Prior art rectal speculums for use with colon hydrotherapyare typically formed from a single piece of material. Conventionaldesigns take the form of a hollow cylindrical tubular member having adistal end for insertion into a patient's rectum and a proximal end forconnection to a waste discharge hose, and an inlet tube which intersectswith the hollow cylindrical tubular member for directing fluid into thehollow cylindrical tubular member. The prior art speculums are usuallyformed of a rigid material that will not deform or flex when broughtinto contact with another body. As a consequence, the rectal speculumcan often be easily felt by a patient during insertion, positioning, anduse, thereby creating an uncomfortable feeling for the patient. Inaddition, a slight hand pressure on the hollow cylindrical tubularmember can be magnified into a higher force at the distal tip of thehollow cylindrical tubular member that is inserted and positioned withina patient's rectum.

The prior art rectal speculums are inserted into a patient's rectum withthe assistance of an obturator which typically includes an elongatedmember having a tapered end capable of extending through the distal endof the rectal speculum and a handle end for assisting in the insertionand removal of the obturator within the rectal speculum. Like the priorart rectal speculums, the obturators are formed form a single piece ofrigid material that will not deform or flex when brought into contactwith another body. As a result, a patient also feels the discomfort ofthe obturator during the insertion and placement of the rectal speculum.

Accordingly, the patient suffers greater pain and discomfort thannecessary using prior art rectal speculums and obturators. Therefore, aneed exists for a new and improved rectal speculum that is easy toposition and use and that is also comfortable to the patient duringplacement and use. A need also exists for a new and improved obturatorthat can be easily used with the new and improved rectal speculum tofurther enhance a patient's comfort during the placement and use of thenew and improved rectal speculum.

SUMMARY OF THE INVENTION

The present invention is directed to a soft dual-layer rectal speculumfor use with colon hydrotherapy that includes a main tube member whereinat least a portion of the main tube member is comprised of an innerfirm, or hard, layer and an outer soft layer which adheres to the innerhard layer and an inlet tube member intersecting the main tube memberfor directing fluids into the main tube member. The main tube memberincludes a distal end for insertion into a patient's rectum and aproximal end for connection to a waste removal hose. In addition, thediameter of the inlet tube member is smaller than the diameter for themain tube member.

The outer soft layer of the main tube member adheres to the inner hardlayer of the main tube member and this adhesion may be formed by one ormore of thermal bonding, chemical bonding, or mechanical bonding. In oneexemplary embodiment of the soft dual-layer rectal speculum of thepresent invention, the inner hard layer and the outer soft layer of themain tube member are created by a two step molding process where theinner hard layer is molded first and the outer soft layer is moldedsecond such that the outer soft layer adheres to the inner hard layer.The inner hard layer may comprise one or more of a polypropylene andsynthetic resin and the outer soft layer may comprise one or more of apolyethylene, a silicone, a soft urethane, a thermoplastic elastomer,and a thermoplastic polyurethane.

In another exemplary embodiment of the soft dual-layer rectal speculumof the present invention, the outer soft layer of at least a portion ofthe main tube member is transparent. In still another exemplaryembodiment of the soft dual-layer rectal speculum of the presentinvention, the portion of the main tube member that comprises an innerhard layer and an outer soft layer further comprises a measurement gaugethat is visible through the outer soft layer. The measurement gauge maybe imprinted within, or tooled into, the hard inner layer.

In yet another exemplary embodiment of the soft dual-layer rectalspeculum of the present invention, the soft dual-layer rectal speculumfurther includes a thumb rest extending outward from an outer surface ofthe main tube member opposite the inlet tube member. The thumb rest maytake one of many different forms including, but not limited to, a flangeor bar member.

In another exemplary embodiment of the soft dual-layer rectal speculumof the present invention, the proximal end of the main tube memberincludes one or more ribs for securing the proximal end of the main tubemember to a waste removal hose. In yet another exemplary embodiment ofthe soft dual-layer rectal speculum of the present invention, the inlettube member includes a swivel mechanism capable of enabling a fluid lineconnected to the inlet tube member to rotate in relation to the maintube member.

The main tube member of the soft dual-layer rectal speculum of thepresent invention may comprise a distal portion located near the distalend of the main tube member and a proximal portion located near theproximal end of the main tube member. In use, most of the distal portionof the main tube member is inserted into a patient's rectum while theproximal portion of the main tube member remains external to thepatient. In this exemplary embodiment, the distal portion of the maintube member includes an inner hard layer and an outer soft layer and theinlet tube member is located on the proximal portion of t he main tubemember near the proximal end of the main tube member. In anotherexemplary embodiment, the distance between the distal portion of themain tube member and the inlet tube member is at least greater than onehalf of the length of the distal portion of the main tube member toenable waste and fluid lines connected to the soft dual-layer rectalspeculum to be further away from the patient during use.

Like the previously described exemplary embodiments, the outer softlayer of the distal portion of the main tube member adheres to the innerhard layer of the distal portion of the main tube member and thisadhesion may be performed by one or more of thermal bonding, chemicalbonding, or mechanical bonding. In addition, the exemplary embodiment ofthe soft dual-layer rectal speculum that includes a main tube memberhaving a proximal portion comprising an inner hard layer and an outersoft layer may further include one or more of a transparent outer softlayer, a measurement gauge visible through a transparent outer softlayer, and a hard inner layer that is imprinted or tooled with ameasurement gauge.

In yet another exemplary embodiment, the distal portion of the main tubemember which includes an inner hard layer and an outer soft layerfurther includes an annular depression. In still another exemplaryembodiment, the distal portion of the main tube member may furtherinclude annular expansions on opposite sides of the annular depression.Further, the inner hard layer may comprise one or more of apolypropylene and a synthetic resin and the outer soft layer maycomprise one or more of a polyethylene, a silicone, a soft urethane, athermoplastic elastomer, and a thermoplastic polyurethane.

The present invention is also directed to a rectal speculum assembly foruse with colon hydrotherapy which includes a main tube member with atleast a portion of the tube member having an inner hard layer and anouter soft layer and an inlet tube intersecting the main tube member fordirecting fluids into the main tube member, and an obturator removablypositioned within the main tube member wherein the obturator includes anelongated member having a tapered distal end capable of extendingthrough the distal end of the main tube member and a proximal end havinga handle portion for assisting in the insertion and removal of theobturator within the main tube member. In one exemplary embodiment ofthe rectal speculum assembly, the tapered distal end of the obturator ismade of a soft, pliable material. The soft pliable material may compriseone or more of polyethylene, silicone, soft urethane, thermoplasticelastomer, or thermoplastic polyurethane.

In another exemplary embodiment of the rectal speculum assembly, thetapered distal end of the obturator is made of an inner hard layer andan outer soft layer. The inner hard layer may comprise one or more of apolypropylene and a synthetic resin and the outer soft layer maycomprise one or more of a polyethylene, a silicone, a soft urethane, athermoplastic elastomer, and a thermoplastic polyurethane.

In yet another exemplary embodiment of the rectal speculum assembly, theelongated member of the obturator may include one or more stabilizingflanges.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject invention will hereinafter be described in conjunction withthe appended drawing figures, wherein like numerals denote likeelements, and

FIG. 1 is a perspective view of an exemplary embodiment of a rectalspeculum in accordance with the present invention;

FIG. 2 is a perspective view of an exemplary embodiment of an obturatorin accordance with the present invention wherein the obturator fitsinside the rectal speculum of the present invention;

FIG. 3 is a cross-sectional view of the rectal speculum of the presentinvention taken along lines 3-3, as shown in FIG. 1;

FIG. 4 is a cross-sectional view similar to FIG. 3 showing analternative embodiment of the two layers which comprise at least aportion of the main tube member of the rectal speculum;

FIG. 5 is a cross-sectional view similar to FIG. 3 shoving anotheralternative embodiment of the two layers which comprise at least aportion of the main tube member of the rectal speculum;

FIG. 6 is a perspective view of another exemplary embodiment of a rectalspeculum in accordance with the present invention;

FIG. 7 is a perspective view of a rectal speculum assembly in accordancewith the present invention showing the obturator depicted in FIG. 2positioned within the exemplary rectal speculum shown in FIG. 6 and afluid source connected to the inlet tube member of the rectal speculum;and

FIG. 8 is yet another exemplary embodiment of a rectal speculum inaccordance with the present invention.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The soft dual-layer rectal speculum and rectal speculum assembly of thepresent invention generally provide a rectal speculum and rectalspeculum assembly that are both easy to position and use and that arealso comfortable to a patient or client during placement and use. Thesoft dual-layer rectal speculum of the present invention includes anunobstructed main tube member with a distal end adapted to be insertedinto a patient's rectum and a proximal end adapted to be connected to awaste removal hose and an inlet tube member that is connectible to asource of water or other treating fluid to permit injection of the fluidinto the main tube member. At least a portion of the main tube memberincludes an inner hard layer and an outer soft layer.

FIG. 1 is a perspective view of an exemplary embodiment of a rectalspeculum 10 in accordance with the present invention. Rectal speculum 10includes a main tube member 12 having a distal end 14 for insertion intoa patient's rectum and a proximal end 16 for connection to a wasteremoval hose. At least a portion of the main tube member 12 includes aninner hard layer and an outer soft layer as further shown and describedwith reference to FIGS. 3-5. Rectal speculum 10 also includes an inlettube member 18 for directing fluids into the main tube member 12.

Inlet tube member 18 intersects main tube member 12 near the proximalend 16 of main tube member 12 and inlet tube member 18 has a diameterthat is smaller than the diameter of main tube member 12. Inlet tubemember 18 extends from near the proximal end 16 of main tube member 12in a position and orientation that prevents kinking of the tubing thatis connected to the inlet tube member 18 to enable free flow of water orother treating fluid into main to be member 12. Water inlet tube 18 canbe designed such that it will maintain a ten degree reverse fluid flowto facilitate the Venturi Effect, namely the reduction in fluid pressurethat results when fluid flows through a constricted section of pipe, forelimination purposes. In another exemplary embodiment, the inlet tubemember 18 may include a swivel mechanism which is further shown anddescribed with reference to FIG. 8.

Main tube member 12 of rectal speculum 10 include a distal portion Xlocated near the distal end 14 of main tube member 12 and a proximalportion located near the proximal end 16 of main tube member 12. In use,most of the distal portion X of the main tube member 12 is inserted intoa patients rectum while the proximal portion Y of the main tube member12 remains external to the patient. In accordance with an exemplaryembodiment of the soft dual-layer rectal speculum of the presentinvention the distal portion X may comprise that portion of the maintube member 12 that includes an inner hard layer and an outer softlayer.

A cross-sectional view of the rectal speculum of the present inventiontaken along lines 3-3 of FIG. 1 is shown in FIG. 3. FIG. 3 shows a crosssection of distal portion X of main tube member 12. Distal portion X ofmain tube member 12 includes an inner hard layer 32 made of a hard,strong, durable lightweight plastic or polymer material and an outersoft layer 34 made of a soft, pliable material. The inner hard layer 32may comprise one or more of a polypropylene or a synthetic resin and theouter soft layer 34 may comprise one or more of a polyethylene asilicone a soft urethane, a thermoplastic elastomer, or a thermoplasticpolyurethane.

The outer soft layer 34 adheres to the inner hard layer 32 and theadhesion of the outer soft layer 34 to the inner hard layer 32 may beperformed by one or more techniques including, but not limited to,thermal bonding, chemical bonding, and mechanical bonding. In oneexemplary embodiment, the distal portion X of main tube member 12 havinginner hard layer 32 and outer soft layer 34 is created by a two stepinjection molding process where the inner hard layer 32 is molded firstand the outer soft layer 34 is molded second such that the outer softlayer 34 adheres to the inner hard layer 32. Further, outer soft layer34 preferably comprises as many as possible of the followingcharacteristics: soft touch; rubbery feel; excellent colorability: highflow for long, thin-wall parts; adhesion to polypropylene; and goodozone and UV resistance. In addition outer soft layer 34 may be clear,transparent, or translucent to enable another exemplary embodiment ofthe soft dual-layer rectal speculum that includes measurement gauge thatis visible through the outer soft layer 34. One example of a materialthat meets most all of these characteristics for the outer soft layer 34is STARFLEX P 7012-1001 manufactured by Star Thermo plastic Alloys andRubbers Inc. located in Broadview, Ill.

FIG. 3 shows the inner hard layer 32 of distal portion X of main tubemember 12 having a same thickness as the outer soft layer 34 of distalportion X of main tube member 12. Inner hard layer 32 and outer hardlayer 34 may also comprise other thicknesses depending on the intendeduse of the soft dual-layer rectal speculum or the patient for which thesoft dual-layer rectal speculum will be used. Other exemplaryembodiments of the soft dual-layer rectal speculum having variousthicknesses for inner hard layer 32 and outer hard layer 34 are shown inFIGS. 4 and 5. FIG. 4 is a cross-sectional view similar to FIG. 3showing an alternative embodiment of the two layers which comprise atleast a portion of the ma in tube member 12 of t he rectal speculum 10.In this embodiment, outer soft layer 34 has a thickness that is greaterthan inner hard layer 32. FIG. 5 is a cross-sectional view similar toFIG. 3 showing another alternative embodiment of the two layers whichcomprise at least a portion of the main tube member 12 of the rectalspeculum 10. In this embodiment, inner hard layer 32 has a thicknessthat is greater than outer soft layer 34.

In another exemplary embodiment of the soft dual-layer rectal speculum10 of the present invention, the distance between the distal portion Xof the main tube member 12 and inlet tube member 18 is at least greaterthan one half of the length of the distal portion X of main tube member12 to enable waste and fluid lines connected to the soft dual-layerrectal speculum to be further away from a patient during use. Thisexemplary embodiment can be seen in FIG. 1 where the distance betweendistal portion X of main tube member 12 and inlet tube member 18 isdenoted as length Z and one half the length of distal portion X isdenoted as length W. As shown in FIG. 1, length Z is greater than lengthW. Moreover, in the same or another exemplary embodiment, the softdual-layer rectal speculum of the present invention is approximately oneinch longer in length than current prior art rectal speculums for use incolon hydrotherapy and this additional length is added to the hoseconnection portion (i.e. the proximal portion Y) of the main tube member12. This additional length has no impact on the insertion or penetrationlength into the patient/client and allows the practitioner more accessfor the insertion procedure. In addition, the added length to proximalportion Y increase patient/client comfort, eliminates possiblerestrictions due to the physical requirements of the patient/client, andprovides added stability during insertion of the soft dual-layer rectalspeculum.

The exemplary embodiment of the soft dual-layer rectal speculum shown inFIG. 1 further includes a thumb rest 22 extending outward from the outersurface of the proximal portion Y of main tube member 12 opposite inlettube member 18. In addition, to assist in retaining the rectal speculumin place during use, the distal portion X of the soft dual-layer rectalspeculum of the present invention shown in FIG. 1 includes an annulardepression 24 that extends about the speculum for receiving the normallycontracted rectal sphincter muscle and annular expansions 26 on oppositesides of the annular depression to prevent axial translation of therectal speculum as result of interference with the rectal sphinctermuscle.

FIG. 2 is a perspective view of an exemplary embodiment of an obturator20 in accordance with the present invention wherein the obturator 20fits inside the rectal speculum of the present invention to facilitateinsertion of the rectal speculum into the patient's rectal canal andlower intestine. Obturator 20 includes an elongated member 27 having atapered distal end 28 capable of extending through the distal end 14 ofmain tube member 12 of rectal speculum 10 and a proximal end 29 having ahandle portion for assistance in inserting the obturator 20 into themain tube member 12 and removing the obturator 20 from the main tubemember 12. Handle portion of proximal end 29 includes an opening 30 forassisting in pushing the obturator 20 into main tube member 12 and reremoving obturator 20 from main tube member 12. It will be understood bythose skilled in the art that the handle portion of proximal end 29 maycomprise any number of designs and configurations as long as the handleportion assists a user in inserting and removing the obturator into andout of the main tube member 12 of rectal speculum 10.

Tapered distal end 28 of obturator 20 may comprise a soft pliablematerial. The soft pliable material may include one or more of apolyethylene, a silicone, a soft urethane, a thermoplastic elastomer, ora thermoplastic polyurethane. Alternatively, tapered distal end 28 ofobturator 20 may comprise an inner hard layer (or inner hard member) andan outer soft layer such as those described with reference to the softdual-layer rectal speculum shown in FIG. 1. The inner hard layer (ormember) may comprise one or more of a polypropylene or a synthetic resinand the soft outer layer may comprise one or more of a polyethylene, asilicone, a soft urethane, a thermoplastic elastomer, or a thermoplasticpolyurethane. In addition, the elongated member 27 of obturator 20 mayinclude one or more stabilizing flanges 40 to provide more stabilityduring the insertion process.

FIG. 6 is a perspective view of another exemplary embodiment of a rectalspeculum in accordance with the present invention. Soft dual-layerrectal speculum 50 includes a main tube member 52 having a distal end 54for insertion into a patient's rectum and a proximal end 56 forconnection to a waste removal hose. At least a portion of the main tubemember 52 includes an inner hard layer and an outer soft layer aspreviously described with reference to FIG. 1 and as previously shownand described with reference to FIGS. 3-5. Rectal speculum 50 alsoincludes an inlet tube member 58 for directing fluids into the main tubemember 52.

Inlet tube member 58 intersects main tube member 52 near the proximalend 56 of main tube member 52 and inlet tube member 58 has a diameterthat is smaller than the diameter of main tube member 52. Inlet tubemember 58 extends from near the proximal end 56 of main tube member 52in a position and orientation that prevents kinking of the tubing thatis connected to the inlet tube member 58 to enable free flow of water orother treating fluid into main to be member 52. Water inlet tube 58 canbe designed such that it will maintain a ten degree reverse fluid flowto facilitate the Venturi Effect, namely the reduction in fluid pressurethat results when fluid flows through a constricted section of pipe, forelimination purposes.

Main tube member 52 of rectal speculum 50 may include a distal portion Xlocated near the distal end 54 of main tube member 52 and a proximalportion located near the proximal end 56 of main tube member 52. In use,most of the distal portion X of the main tube member 52 is inserted intoa patients rectum while the proximal portion Y of the main tube member52 remains external to the patient. In accordance with an exemplaryembodiment of the soft dual-layer rectal speculum of the presentinvention the distal portion X may comprise that portion of the maintube member 52 that includes an inner hard layer and an outer softlayer.

The inner hard layer and outer soft layer of distal portion X of maintube member 52 may comprise any of those materials previously discussedwith reference to the inner hard layer and outer soft layer of the softdual-layer rectal speculum shown and described in FIG. 1 In addition thethicknesses of the inner hard layer and the outer soft layer maycomprise any of those embodiments previously discussed with reference toFIGS. 3-5. Moreover, adhesion of the outer soft layer to the inner hardlayer may be performed by any of those methods previously described withreference to the soft dual-layer rectal speculum shown and described inFIG. 1.

Like the soft dual-layer rectal speculum shown and described in FIG. 1,the exemplary embodiment of the soft dual-layer rectal speculum shown inFIG. 6 also includes a thumb rest 62 extending outward from the outersurface of the proximal portion Y of main tube member 52 opposite inlettube member 58. Thumb rest 62 assists in keeping the rectal speculum 50steady while the obturator 20 is moved and a waste removal hose isattached to the proximal end 56 of main tube member 52. When removingobturator 20 from main tube member 52 and attaching the waste removalhose, a technician or physician can grasp the speculum 50 between his orher thumb and index finger and place the distal side of the thumb rest62 against the back of his or her thumb. The resulting steady forceexerted by the hand resists movement of the speculum 50 during removalof the obturator and attachment of the waste removal hose. The softdual-layer rectal speculum shown in FIG. 6 also includes one or moreribs 63 at the proximal end 56 of main tube member 52 to allow forbetter cohesion when the waste removal hose is connected to the rectalspeculum 50 and to prevent leaking of waste at the proximal end 56 ofrectal speculum 50.

A perspective view of a rectal speculum assembly in accordance with thepresent invention showing the obturator depicted in FIG. 2 positionedwithin the exemplary rectal speculum shown in FIG. 6 and a fluid sourceconnected to the inlet tube member of t he rectal speculum is shown inFIG. 7. The tapered distal end 28 of the obturator 20 and most of thedistal portion X of main tube member 52 of speculum 50 are inserted intoa patient's rectum. The obturator 20 is then removed from the rectalspeculum 50 by utilizing the handle, portion (in this case opening 30)of proximal end 29 of obturator 20 to pull obturator 20 out of rectalspeculum 50. Water or treating fluid is then injected through inlet tubemember 58 and resulting waste exits the rectal speculum 50 at theproximal end 56 of the speculum 50 which is attached to a waste removalhose.

FIG. 8 is yet another exemplary embodiment of a rectal speculum 70 inaccordance with the present invention. The soft dual-layer rectalspeculum 70 shown in FIG. 8 is almost identical to the soft dual-layerrectal speculum 10 shown in FIG. 1 with three exceptions—the inclusionof a measurement gauge visible through the outer soft layer of thedistal portion X of the main tube member, the inclusion of a swivelmechanism in the inlet tube member, and the addition of one or more ribsat the proximal end of the main tube member.

Rectal speculum 70 includes a main tube member 72 having a distal end 74for insertion into a patient's rectum and a proximal end 76 forconnection to a waste removal hose. At least a portion of the main tubemember 72 includes an inner hard layer and an outer soft layer asfurther shown and described with reference to FIG. 1 and as previouslyshown and described with reference to FIGS. 3-5. Rectal speculum 70 alsoincludes an inlet tube member 78 for directing fluids into the main tubemember 72.

Inlet tube member 78 intersects main tube member 72 near the proximalend 76 of main tube member 72 and inlet tube member 78 has a diameterthat is smaller than the diameter of main tube member 72. Inlet tubemember 78 includes a swivel mechanism 73 which is capable of enabling afluid line connected to the inlet tube member 78 to rotate in relationto the main tube member 72. Swivel mechanism 73 provides a 360 degreeaccess allowing the water or treating fluid hose to be repositionedduring the course of the treatment to facilitate the needs, physicalrequirements, and comfort of the patient/client while providing thepractitioner with the flexibility to manage the treatment session foroptimum results. Swivel mechanism 73 also prevents the water or treatingfluid line from kinking and prevents back flow to the pressure gaugewhich can result in the gauge blowing at the diaphragm.

Main tube member 72 of rectal speculum 70 may include a distal portion Xlocated near the distal end 74 of main tube member 72 and a proximalportion Y located near the proximal end 76 of main tube member 72. Inuse, most of the distal portion X of the main tube member 72 is insertedinto a patient's rectum while the proximal portion Y of the main tubemember 72 remains external to the patient. In accordance with anexemplary embodiment of the soft dual-layer rectal speculum of thepresent invention, the distal portion X may comprise that portion of themain tube member 72 that includes an inner hard layer and an outer softlayer.

Then inner hard layer and outer soft layer of distal portion X of maintube member 72 may comprise any of those materials previously discussedwith reference to the inner hard layer and outer soft layer of the softdual-layer rectal speculum shown and described in FIG. 1. In addition,the thicknesses of the inner hard layer and the outer soft layer maycomprise any of those embodiments previously discussed with reference toFIGS. 3-5. Moreover, adhesion of the outer soft layer to the inner hardlayer may be performed by any of those methods previously described withreference to the soft dual-layer rectal speculum shown and described inFIG. 1.

Like the soft dual-layer rectal speculum shown and described in FIGS. 1and 6, the exemplary embodiment of the soft dual-layer rectal speculumshown in FIG. 8 also includes a thumb rest 82 extending outward from theouter surface of the proximal portion Y of main tube member 72 oppositeinlet tube member 78. The soft dual-layer rectal speculum shown in FIG.8 also includes one or more ribs 83 at the proximal end 76 of main tubemember 72 to allow for better cohesion when the waste removal hose isconnected to the rectal speculum 70 and to prevent waste from leaking atthe proximal end 76 of rectal speculum 70. In addition, the distalportion X of the main tube member 72 of rectal speculum 70 includes ameasurement gauge 85 that is visible through the outer soft layer of thedistal portion X. In this exemplary embodiment, the outer soft layer isclear, transparent, or translucent so that measurement gauge 85 can beread through the outer soft layer. Measurement gauge 85 may be imprintedor tooled into the inner hard layer of distal portion X prior toadhering the outer soft layer to the inner hard layer. The gaugemarkings will assist the practitioner by providing an accurate insertionmeasurement to facilitate the comfort of the patient/client. Themeasurement gauge markings will not be felt through the outer soft layerof the speculum.

The detailed description of exemplary embodiments of the inventionherein show various exemplary embodiments and the best modes, known tothe inventor at this time, of the invention. These exemplary embodimentsand modes are described in sufficient detail to enable those skilled inthe art to practice the invention and are not intended to limit thescope, applicability, or configuration of the invention in any way.Rather, the following disclosure is intended to teach both theimplementation of the exemplary embodiments and modes and any equivalentmodes or embodiments that are known or obvious to those reasonablyskilled in the art. Additionally, all included figures are non-limitingillustrations of the exemplary embodiments and modes, which similarlyavail themselves to any equivalent modes or embodiments that are knownor obvious to those reasonably skilled in the art.

Other combinations and/or modifications of structures, arrangements,applications, proportions, elements, materials, or components used inthe practice of the instant invention, in addition to those notspecifically recited, can be varied or otherwise particularly adapted tospecific environments, manufacturing specifications, design parameters,or other operating requirements without departing from the scope of theinstant invention and are intended to be included in this disclosure. Itwill be understood by those skilled in the art that ail or some of themain tube member of the rectal speculum includes and inner hard layerand an outer soft layer a long as at least a portion of the main tubemember includes an inner hard layer and an outer soft layer.

Unless specifically noted, it is the Applicant's intent that the wordsand phrases in the specification and the claims be given the commonlyaccepted generic meaning or an ordinary and accustomed meaning used bythose of ordinary skill in the applicable arts. In the instance wherethese meanings differ, the words and phrases in the specification andthe claims should be given the broadest possible, generic meaning. Ifany other special meaning is intended for any word or phrase, thespecification will clearly state and define the special meaning. Theterms “client” and “patient” are used interchangeably throughout thespecification as are the terms “practitioner”, “physician”, and“technician”.

1. A dual-layer rectal speculum for use with colon hydrotherapycomprising: a main tube member having a distal end for insertion into apatients rectum and a proximal end for connection to a waste removalhose wherein at least a portion of the main tube member comprises aninner hard layer and an outer soft layer; and an inlet tube member fordirecting fluids into the main tube member wherein the inlet tube memberhas a diameter less than a diameter of the main tube member and a swivelmechanism capable of enabling a fluid line connected to the inlet tubemember to rotate in relation to the main tube member.
 2. The dual-layerrectal speculum of claim 1 wherein the portion of the main tube membercomprising an inner hard layer and an outer soft layer is created by atwo step molding process where the inner hard layer is molded first andthe outer soft layer is molded second such that the outer soft layeradheres to the inner hard layer.
 3. The dual-layer rectal speculum ofclaim 1 wherein the inner hard layer comprises at least one of apolypropylene and a synthetic resin and the outer soft layer comprisesat least one of a polyethylene, a silicone, a soft urethane, athermoplastic elastomer, and a thermoplastic polyurethane.
 4. Thedual-layer rectal speculum of claim 1 w herein the outer soft layer istransparent.
 5. The dual-layer rectal speculum of claim 1 wherein themain tube member further comprises a measurement gauge visible throughthe outer soft layer.
 6. The dual-layer rectal speculum of claim 1further comprising a thumb rest extending outward from an outer surfaceof the main tube member opposite the inlet tube member.
 7. Thedual-layer rectal speculum of claim 1 wherein the proximal end of themain tube member includes one or more ribs for securing the proximal endof the main tube member to a waste removal hose.
 8. The dual-layerrectal speculum of claim 1 wherein the inlet tube member intersects themain tube member near the proximal end of the main tube member.
 9. Thedual-layer rectal speculum of claim 1 wherein the main tube memberfurther comprises a distal portion located near the distal end of themain tube member and a proximal portion located near the proximal end ofthe main tube member.
 10. The dual-layer rectal speculum of claim 9wherein the inlet tube member is located on the proximal portion of themain tube member near the proximal end of the main tube member.
 11. Thedual-layer rectal speculum of claim 10 wherein the distance between thedistal portion of the main tube member and the inlet tube member is atleast greater than one half of the length of the distal portion of themain tube member to enable waste and fluid lines connected to thedual-layer rectal speculum to be further away from a patient during use.12. The dual-layer rectal speculum of claim 9 wherein the distal portionof the main tube member comprises an inner hard layer and an outer softlayer.
 13. The dual-layer rectal speculum of claim 12 wherein the outersoft layer adheres to the inner hard layer.
 14. The dual-layer rectalspeculum of claim 13 herein adhesion of the outer soft layer to theinner hard layer is performed by at least one of thermal bonding,chemical bonding, and mechanical bonding.
 15. The dual-layer rectalspeculum of claim 12 wherein the distal portion of the main tube memberfurther comprises an annular depression.
 16. The dual-layer rectalspeculum of claim wherein the distal portion further comprises annularexpansions on opposite sides of the annular depression.
 17. Thedual-layer rectal speculum of claim 12 wherein the inner hard layercomprises at least one of a polypropylene and a synthetic resin and theouter soft layer comprises at least one of a polyethylene, a silicone, asoft urethane, a thermoplastic elastomer, and a thermoplasticpolyurethane.
 18. The dual-layer rectal speculum of claim 12 wherein theouter soft layer is transparent.
 19. The dual-layer rectal speculum ofclaim 18 wherein the main tube member further comprises a measurementgauge visible through the outer soft layer.
 20. The dual-layer rectalspeculum of claim 19 wherein the measurement gauge is imprinted within,or tooled into, the inner hard layer of the main tube member.
 21. Arectal speculum assembly for use with colon hydrotherapy comprising: amain tube member having a distal end for insertion into a patient'srectum and a proximal end for connection to a waste removal hose whereinat least a portion of the main tube member comprises an inner hard layerand an outer soft layer; an inlet tube member for directing fluids intothe main tube member wherein the inlet tube member has a diameter lessthan a diameter of the main tube member and a swivel mechanism capableof enabling a fluid line connected to the inlet tube member to rotate inrelation to the main tube member, and an obturator removably positionedwithin the main tube member of the dual-layer rectal speculum forfacilitating insertion of the dual-layer rectal speculum in a patient'srectum wherein the obturator comprises an elongated member having atapered distal end capable of extending through the distal end of themain tube member and a proximal end having a handle portion forassistance in inserting the obturator into the main tube member andremoving the obturator from the main tube member.
 22. The rectalspeculum assembly of claim 21 wherein the tapered distal end of theobturator comprises a soft pliable material.